Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

A Woman Relegated To The Manufacturing Night Shift

After graduating with a biology degree from Howard University and entering the pharma industry, Stephanie Wimberly found herself the only woman — the only black woman — in a manufacturing facility in Maryland. A supervisor made it clear he didn’t want her on his team; she was reassigned to the night shift at her facility. “I had a family to support, and night shift, or abuse, was not what I signed up for,” she says. “But I didn’t have many options.” Here is how she persevered, and prospered.

GUEST COLUMNISTS

Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
The Real Reason We Haven't Fully Automated Cell Therapy Yet
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.
The Firefighting Era Of Clinical Supply Chain Is Over. Here's What Replaces It
Clinical trial supply chains are evolving: digital twins, on-demand kits, and sustainable logistics replace reactive firefighting with precision, speed, and resilience.
The Hidden Engineering Behind Successful Upstream Bioprocessing
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
A Practical Look At Modern Downstream Processing For Biologics
Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.
Process Engineering's Key Role In Sterile Injectable Facility Design
Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

PHARMA OUTSOURCING WHITE PAPERS

Accelerated Development Of Solid Oral Dosage Formulation For IND Submission
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

In Vivo Testing Of Nasal Dosage Forms
Innovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.
Advancing A LNP Formulation To Clinical And Commercial Manufacturing
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
Project Management: Sphere Of Influence
The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.
Developing Pulmonary Dosage Forms For Complex Molecule Delivery
Discover how next-generation inhalation technologies can transform pulmonary drug delivery and unlock new therapeutic possibilities for a wide range of respiratory diseases.
Enabling Digital Twins With Computational Fluid Dynamics Modeling
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.